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September 6, 2011

Potential Changes to US Federal Common Rule May Have Important Implications for Health Information Management

Arnold & Porter Advisory

On July 26, 2011, the US Department of Health and Human Services (HHS) announced its intention to modify current regulations (the "Common Rule") governing human research subject protections. The advanced notice of proposed rulemaking (ANPR) poses several possible changes to the Common Rule that could have a significant impact on pharmaceutical and medical device manufacturers, research institutions, institutional review boards, and other entities involved in clinical research. In response to criticisms of the current framework through which HHS and other Common Rule agencies regulate human subject research, HHS suggests changes to several aspects of the current regulatory framework, with the goal of enhancing the effectiveness of the research oversight system.

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